FDA 483 - Apollo Care, LLC - March 13, 2018

The FDA Form 483 details numerous deficiencies at a facility manufacturing sterile injectable drug products, including Vancomycin and Sodium Bicarbonate. A critical finding is the absence of a Quality Control Unit with authority to approve/reject procedures and products.

Key violations include: - **Quality System:** No written SOPs for complaint review, labeling, or master labels. Existing SOPs are incomplete, inaccurate, and not followed (e.g., document corrections, cleaning procedures, gowning). - **Component Control:** Failure to perform identity testing on components. Raw materials like Sodium Chloride Injection and Sterile Water for Injection are used without Certificates of Analysis or additional testing. Quarantined materials are not properly labeled or segregated. Materials are stored directly on the floor, and temperature-sensitive products are in unmonitored areas. - **Manufacturing & Process Control:** Deficient visual inspection (no black background, no documentation). No Quality Unit review of processing records before distribution. - **Investigations:** Failure to investigate out-of-specification stability results for Vancomycin, leading to continued distribution of affected products. No investigations for environmental monitoring excursions. - **Personnel:** Lack of documented training records for personnel involved in sterile processing prior to 1/9/18. - **Aseptic Processing:** Aseptic operators are not initially qualified by media fills. Smoke studies are deficient, not simulating actual operations. Media fills are inadequate, not simulating complete sterile operations or worst